Software provides records for regulatory audits
processes provides auditable records to help food companies meet
regulatory requirements.
The software is designed to provide the records needed for compliance under the US Bioterrorism Act and for Food and Drug Administration regulations. It also provides records on energy use, product loss and production data for enterprise resource planning (ERP) systems.
Most food processing companies still rely on the manual data entry of production results and ingredient usage, despite massive investments in ERP systems. Vigilistics collects accurate and auditable production data in a template form, the company stated yesterday.
"Today with Vigilistics, in five seconds, dairy plant managers can trace from finished products back to the specific deliveries of milk to the plant," stated Craig Nelson, the company's founder and chief technical officer. "They can then trace that load of milk through every path in the plant and determine which products contain that delivery, even in trace amounts. This would take many hours with other systems."
Vigilistics software integrates with existing plant systems. In trials at installation sites, the Vigilistics systems were used for operations in fluid dairy, cheese, powdered milk, soup and other foods.
Vigilistics says the software is now ready for use by food manufacturing plants. Until now, no packaged, configurable software was available that meets the requirement and intent of the regulations, Nelson stated.
In addition to the tracking and tracing required by the Bioterrorism Act, Vigilistics also monitors real-time inventory and provides built-in reports for FDA compliance, cleaning-in-place and batch runs. The FDA has approved Vigilistics to replace chart recorders for legal compliance systems.
The software release yesterday is the result of a four-year effort to develop and prove the success of a configurable application that addresses the specific needs of the food processing industry, Nelson stated.
"Our initial objective of providing auditable tracking and tracing has been achieved and proven to meet the requirements of the Bioterrorism Act and the FDA -- requirements that all food and dairy manufacturers must comply with," he stated. "We also have found many opportunities for economic benefits, often paying for the installation in less than six months."
In tests with an unnamed dairy processor, the software helped the company save about $1m per year in direct costs by monitoring, detecting, and preventing milk loss during processing, Nelson claims.
Another company saved about $250,000 per year in wastewater charges.
Two of the seven early adopters of Vigilistics have automated the input to their ERP system, thus eliminating operator entry and improving information at the enterprise level.
The Bioterrorism Act was passed in 2002 to ensure the safety of the US food supply from a terrorist attack.
Among other procedures required under the law, the act requires all domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption to register the with FDA.
Section 306 of the act, issued as an interim rule, also mandates strict record keeping requirements for those who manufacture, process, pack, transport, distribute, receive, hold or import food to the US.
In December 2004, the FDA published a final rule requiring food firms to establish and maintain records that would allow inspectors to conduct an effective and traceback investigation to protect the food and animal feed supply.
The FDA estimates that about 420,000 food facilities are required to register under the act, of which half are domestic companies. As of January 18 last year, about 238,129 had registered, of which 107,043 were domestic companies.
